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HIV Screening Take-up: Evaluating Incentives and Opt-out Strategies

This study has been completed.
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute on Aging (NIA)
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01377857
First received: June 18, 2011
Last updated: May 13, 2015
Last verified: May 2015
History of Changes

June 18, 2011
May 13, 2015
May 2011
December 2013   (final data collection date for primary outcome measure)
Proportion of patients offered an HIV test who accept [ Time Frame: Monthly ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01377857 on ClinicalTrials.gov Archive Site
  • Proportion testing HIV positive of those tested [ Time Frame: Monthly ] [ Designated as safety issue: No ]
  • Proportion testing HIV positive among those offered a test [ Time Frame: Monthly ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
HIV Screening Take-up: Evaluating Incentives and Opt-out Strategies
HIV Screening Take-up: Evaluating Incentives and Opt-out Strategies
Over twenty percent of HIV-positive persons in the United States are unaware of their infection, leading the Institute of Medicine to recently urge further work to compare the effectiveness of HIV screening strategies. This study will use a randomized trial to compare several variants of emergency-room-based HIV-testing policies in order to determine how HIV test acceptance rates can be increased. The testing policies will be designed using principles from behavioral economics, varying the choice architecture and offering small monetary incentives. This will be the first study to measure differences in take-up rates across a variety of promising but largely untested approaches within a unified randomized trial. Three defaults will be tested: traditional opt-in (test only those patients who request testing), opt-out (routinely testing unless patients decline), and active-choice testing (patients are required to state whether they want to be tested). The study will also be the first to test the effect of small monetary incentives ($1, $5, $10) on test take-up. An additional novel study contribution will be to test the hypothesis that compliance with large requests (accept an HIV test) increases after making a small request or pre-commitment - this "foot in the door" technique has not been previously studied in this setting. The factorial design will permit a direct comparison of all interventions, as well as interactions. The study will contribute a nuanced empirical understanding of how testing protocols from behavioral economics theory affect the effectiveness and efficiency of screening programs in an actual scaled- up setting (San Francisco General Hospital). This will assist in implementing and assessing recent CDC guidelines on HIV screening, while also more generally advancing scientific knowledge related to applying behavioral economics in comparative effectiveness research.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
HIV
  • Behavioral: Monetary Incentive
    $1, $5, or $10 incentive
  • Behavioral: Questionnaire Timing
    Timing of the questionnaire--either before or after testing is offered.
  • Behavioral: HIV Test Offering
    HIV Test will be offered as opt-in, opt-out, or active choice.
  • Experimental: Opt-In
    Opt-in refers to a default of no test - patients must ask for the test in order to receive it. Patients are informed of the availability of rapid testing. They are tested only if they request the test.
    Intervention: Behavioral: HIV Test Offering
  • Experimental: Opt-Out
    Opt-out has a default to test - patients are informed that they will receive a rapid HIV screening test unless they decline it. Patients will be tested unless they decline.
    Intervention: Behavioral: HIV Test Offering
  • Experimental: Active Choice
    In the active choice treatment, there is no default; patients must actively accept or actively decline the test.
    Intervention: Behavioral: HIV Test Offering
  • Experimental: $1 Incentive
    When offering the HIV test, study staff will inform subjects that the ED is offering cash incentives to promote HIV testing (and that the test is also free), and will inform them of that day's value.
    Intervention: Behavioral: Monetary Incentive
  • Experimental: $5 Incentive
    When offering the HIV test, study staff will inform subjects that the ED is offering cash incentives to promote HIV testing (and that the test is also free), and will inform them of that day's value.
    Intervention: Behavioral: Monetary Incentive
  • Experimental: $10 Incentive
    When offering the HIV test, study staff will inform subjects that the ED is offering cash incentives to promote HIV testing (and that the test is also free), and will inform them of that day's value.
    Intervention: Behavioral: Monetary Incentive
  • Experimental: Early Questionnaire
    At a time that does not interfere with patients' medical care, patients will be approached by a member of the research team to consent to and complete a short (3 minutes) questionnaire. The questionnaire is designed to elicit two things: subjective risk of infection (e.g., What are the chances you have HIV? [Not possible, Unlikely, Possible, Likely, Certain]) and objective risk of infection (e.g., In the past year, have you given anyone drugs or money for sex?). The questionnaire will be administered as one of two timing treatments - a) at the beginning of care, before the patient is offered an HIV test (Early questionnaire) or b) after the patient has been offered an HIV test (Late questionnaire).
    Intervention: Behavioral: Questionnaire Timing
  • Experimental: Late Questionnaire
    At a time that does not interfere with patients' medical care, patients will be approached by a member of the research team to consent to and complete a short (3 minutes) questionnaire. The questionnaire is designed to elicit two things: subjective risk of infection (e.g., What are the chances you have HIV? [Not possible, Unlikely, Possible, Likely, Certain]) and objective risk of infection (e.g., In the past year, have you given anyone drugs or money for sex?). The questionnaire will be administered as one of two timing treatments - a) at the beginning of care, before the patient is offered an HIV test (Early questionnaire) or b) after the patient has been offered an HIV test (Late questionnaire).
    Intervention: Behavioral: Questionnaire Timing
  • Experimental: FITD Questionnaire
    There will be two versions of the early questionnaire: one standard Early questionnaire, and one with an additional question: "If you were offered an HIV test as part of your routine health care at no cost, would you get tested?" The two questionnaires will be otherwise identical.
    Intervention: Behavioral: Questionnaire Timing
  • Experimental: Free
    When offering the HIV test, study staff will inform subjects that the ED is offering HIV testing (and that the test is also free); no monetary incentive will be offered.
    Intervention: Behavioral: Monetary Incentive
Montoy JC, Dow WH, Kaplan BC. Patient choice in opt-in, active choice, and opt-out HIV screening: randomized clinical trial. BMJ. 2016 Jan 19;532:h6895. doi: 10.1136/bmj.h6895.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
8572
December 2013
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients aged 13 - 64 years who are awake, alert, not intoxicated, and understand the premise of the test will be offered the test and questionnaire according to their treatment group.

Exclusion Criteria:

  • Patients who have altered levels of consciousness, are critically ill (e.g., serious trauma), are known to have preexisting HIV diagnosis, or who have been tested for HIV in the past 3 months will be excluded from the study.
  • Pregnant patients will be excluded due to alternative guidelines for incorporating opt-out testing during prenatal care.
  • Any patients who are in police custody will also be excluded due to their lack of control over study participation decisions and ethical concerns over possible coercion.
Both
13 Years to 64 Years   (Child, Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01377857
10562983, 1RC4AG039078-01
No
Not Provided
Not Provided
University of California, San Francisco
University of California, San Francisco
  • National Institutes of Health (NIH)
  • National Institute on Aging (NIA)
Principal Investigator: Beth Kaplan, MD University of California, San Francisco
Principal Investigator: William H Dow, PhD University of California, Berkeley
University of California, San Francisco
May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP